Health & Fitness
Health and Fitness
Health and Fitness
Wed, May 19, 2010 Targacept Initiates Phase 2 Study of TC-5619 in Attention Deficit/Hyperactivity Disorder in Adults
WINSTON-SALEM, N.C.--([ BUSINESS WIRE ])--Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that it has initiated a Phase 2 clinical proof of concept trial of TC-5619 in adults with attention deficit/hyperactivity disorder (ADHD). TC-5619 is a novel small molecule that is highly selective for the alpha7 neuronal nicotinic receptor, which Targacept refers to as NNR, and was discovered by Targacept scientists using Targacepta™s proprietary drug discovery platform known as Pentad (TM). Targacept expects this Phase 2 trial of TC-5619 to complete in the first half of 2011.
"In our Phase 1 multiple rising dose study in healthy volunteers, TC-5619 showed beneficial effects on a surrogate measure of attention at doses in the range being studied in this Phase 2 trial, suggesting its promise as a treatment for ADHD"
aIn our Phase 1 multiple rising dose study in healthy volunteers, TC-5619 showed beneficial effects on a surrogate measure of attention at doses in the range being studied in this Phase 2 trial, suggesting its promise as a treatment for ADHD,a said Geoffrey Dunbar, M.D., Senior Vice President, Clinical Development and Regulatory Affairs of Targacept. aThe depth of our pipeline of product candidates being studied in ADHD places us at the forefront of development in this therapeutic area. The pharmacological diversity reflected by TC-5619, an alpha7 modulator, and AZD3480 and AZD1446, both alpha4beta2 modulators, underscore the potential that our NNR Therapeutics have to meet the needs of patients affected by this disorder.a
aStimulants remain the most frequently prescribed therapy for ADHD. But prescriptions for stimulants must be scheduled due to their abuse potential, and they are often associated with serious side effects,a said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. aA new, well-tolerated, non-stimulant treatment option could potentially improve the lives of many of the estimated 23 million adults and 22 million children and adolescents with ADHD.a
The multi-center Phase 2 clinical proof of concept ADHD trial is a double-blind, placebo controlled, randomized, parallel group study being conducted in the United States. The trial is planned to enroll up to 125 patients ages 18 to 65. As with Targacepta™s ongoing Phase 2 clinical proof of concept trial of TC-5619 in cognitive dysfunction in schizophrenia (CDS), the trial design provides for patients to be randomly assigned to one of two cohorts, TC-5619 or placebo, and dosed over a 12-week period. Patients randomized to the TC-5619 arm will be up-titrated every four weeks and tested on each of three doses of TC-5619. The primary efficacy outcome measure of the trial is change from baseline on the Conners Adult ADHD Rating Scale, a multimodal questionnaire assessment of symptoms and behaviors associated with ADHD in adults aged 18 and older.
The ADHD trial is part of a recently expanded development program for TC-5619 that also includes Targacepta™s ongoing Phase 2 clinical proof of concept trial in CDS and other studies planned to be conducted by each of Targacept and its strategic collaborator AstraZeneca to support the potential advancement of TC-5619 into Phase 2 clinical development for Alzheimera™s disease. AstraZeneca has the future right to license TC-5619 for various cognitive disorders under the partiesa™ December 2005 collaboration agreement.
About ADHD
Attention deficit/hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders. The principal characteristics of ADHD are inattention, hyperactivity and impulsivity. ADHD is a chronic disorder that develops during childhood, often persists into adulthood and can negatively impair many aspects of daily life, including home, school, work and interpersonal relationships. The market research firm Business Insights estimated that there were approximately 23.3 million adults and 21.6 million children and adolescents with ADHD in 2009 in the worlda™s seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom and Japan).
About TC-5619
TC-5619 is a novel small molecule that is highly selective for the alpha7 NNR. The alpha7 NNR subtype has been shown to be a key regulator of cognitive function, including attention, memory and learning [1]. Preclinical studies of alpha7 modulators suggest cognition-enhancement in the central nervous system (CNS) [2]. As a result, alpha7 NNR-targeted therapies, used alone or in combination with other drugs, offer a potential new approach to treating the constellation of symptoms associated with CNS diseases and disorders. TC-5619 has little or no interaction with 5HT3 receptors or hERG channels, properties that distinguish it from other alpha7 NNR-targeted compounds and could facilitate a more favorable tolerability profile.
About Targacept
Targacept is a clinical-stage biopharmaceutical company with a vision of building health and restoring independence for patients. Targacept has leveraged its leadership position in NNR research to build a diverse pipeline of NNR Therapeutics (TM) in development to treat an array of central nervous system diseases and disorders, including major depressive disorder, attention deficit/hyperactivity disorder, Alzheimera™s disease and cognitive dysfunction in schizophrenia. In addition, Targacept has alliances with the global pharmaceutical companies AstraZeneca and GlaxoSmithKline. Targacepta™s news releases are available on its website at [ www.targacept.com ].
Forward-Looking Statements
This press release includes aforward-looking statementsa made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements other than statements of historical fact regarding, without limitation: the progress or scope of development of TC-5619, AZD3480 or AZD1446, such as the size, design, subject population, conduct, duration or objective of any clinical trial, the timing for initiation or completion of any clinical trial or for availability of results from any clinical trial, or the indication(s) for which TC-5619, AZD3480 or AZD1446 may be developed; the benefits or competitive position of TC-5619, AZD3480 or AZD1446 or the commercial opportunity in any particular indication; or Targacepta™s plans, expectations or future operations, financial position, revenues, costs or expenses. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various important factors, including, without limitation, risks and uncertainties relating to: the conduct and results of clinical trials and non-clinical studies and assessments of TC-5619, including the performance of third parties engaged to execute such trials, studies and assessments, delays resulting from any changes to the applicable protocols and difficulties or delays in the completion of subject enrollment or data analysis; a decision by AstraZeneca whether to conduct Phase 2 clinical development of TC-5619 for Alzheimera™s disease; a decision by AstraZeneca whether to exercise its option to license TC-5619 when exercisable; the significant control that AstraZeneca has over the development of AZD3480 and AZD1446, including as to the conduct of any further development of AZD3480 or AZD1446 in ADHD; and the timing and success of submission, acceptance and approval of regulatory filings. These and other risks and uncertainties are described in greater detail under the heading aRisk Factorsa in Targacepta™s most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Targacept cautions you not to place undue reliance on any forward-looking statement.
In addition, any forward-looking statement in this press release represents Targacepta™s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Targacept disclaims any obligation to update any forward-looking statement, except as required by applicable law.
NNR Therapeutics (TM) and Pentad (TM) are trademarks of Targacept, Inc. Any other service marks, trademarks and trade names appearing in this press release are the properties of their respective owners.
[1] Leiser, S.C., et al., A cog in cognition: How the alpha7 nicotinic acetylcholine receptor is geared towards improving cognitive deficits, Pharmacol Ther, (2009), doi: 10.1016/jpharmthera.2009.03.009.
[2] Hauser, T.A., et al., TC-5619: An alpha7 neuronal nicotinic receptor-selective agonist that demonstrates efficacy in animal models of the positive and negative symptoms and cognitive dysfunction of schizophrenia. Biochem. Pharmacology 2009; 78: 803-812.
